(252 days)
Not Found
No
The summary describes standard image processing techniques and does not mention AI, ML, or related concepts like deep learning or neural networks. The functions listed are typical of medical image viewing and manipulation software.
No.
ABLATE-IQ™ is a CT image processing software package that assists physicians in identifying ablation targets, assessing proper ablation probe placement, and visualizing treatment zones. It does not perform any direct therapeutic action on a patient.
No
The 'Intended Use / Indications for Use' section explicitly states, "The software is not intended for diagnosis."
Yes
The device is described as a "Computed Tomography (CT) image processing software package" that is resident on a larger system but functions independently via a separate monitor and user interface. Its functions are purely software-based (image manipulation, segmentation, registration, etc.) and it interacts with other systems (PACS, CT scanner) via standard protocols (DICOM). While it is an "optional feature for use with the NEUWAVE Microwave Ablation System," the description focuses solely on the software's capabilities and does not mention any hardware components or hardware-specific functions of ABLATE-IQ™ itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ABLATE-IQ™ "assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones". It explicitly states it is "not intended for diagnosis". IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. ABLATE-IQ™ is used for image processing and guidance during a medical procedure, not for analyzing biological samples.
- Device Description: The description details image processing software that works with CT, PET, and MR images. It connects to a PACS system and CT scanner. This aligns with image-guided therapy, not in vitro diagnostics.
- Lack of Mention of Biological Samples: There is no mention of analyzing blood, tissue, or any other biological specimens, which is a core characteristic of IVD devices.
Therefore, ABLATE-IQ™ is a medical device used for image processing and guidance during microwave ablation procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ABLATE-IO™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.
Product codes
JAK
Device Description
ABLATE-IQ™ formally known as Ablation Confirmation, is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE System. ABLATE-IO™ is resident on the NEUWAVE Microwave Ablation System and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. ABLATE-IQ™ functions are controlled via a USB connected mouse. ABLATE-IQ™ connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol over the hospital network. DICOM enables the integration of scanners, servers, workstations, printers, and network hardware from multiple manufacturers into an electronic PACS.
ABLATE-IQTM contains a wide range of image processing tools, including:
- · 2D image manipulation
- · 3D image generation (from 2D images)
- · 3D image manipulation
- · Region of interest (ROI)/target identification, segmentation, and measurement
- · Image-based detection of ablation probes manually placed by the user (physician)
- · Registration of multiple images into a single view
Mentions image processing
ABLATE-IQ™ formally known as Ablation Confirmation, is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE System.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PET, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ABLATE-IQ™ was tested in accordance with an established test plan that fully evaluated all functions performed by the software. Design verification documents were developed to provide evidence for unit, integration, system level, regression, information security, and validation software tests. Additionally, User Requirement, Design Requirement, and Design Specification testing was reports were developed. The ABLATE-IQ™ software passed all pre-determined acceptance criteria identified in the test plan.
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks arising from the new or updated features were analyzed and satisfactorily mitigated in the device design and labeling.
ABLATE-IQ™ software V3.2.0 is substantially equivalent in design concepts, technologies and operating principle to the identified predicate. This version of the ABLATE-IQ™ does not present any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
April 4, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
NeuWave Medical, Inc. % Allison Francis Regulatory Affairs Specialist 3529 Anderson Street MADISON, WI 53704
Re: K232227
Trade/Device Name: ABLATE-IQTM Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: March 4, 2024 Received: March 4, 2024
Dear Allison Francis:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232227
Device Name ABLATE-IOTM
Indications for Use (Describe)
ABLATE-IO™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the text 'K232227'. The text is in a simple, sans-serif font. The letters and numbers are all the same size and are evenly spaced. The 'K' is the only letter, and the rest of the text is numbers.
Image /page/3/Picture/1 description: The image shows the logo for NeuWave Medical. The logo consists of a green sphere with a white wave design on the left, followed by the text "NeuWave Medical" in a simple, sans-serif font. Below the company name, in smaller letters, it says "PART OF THE ETHICON™ FAMILY OF COMPANIES".
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submission Sponsor: NeuWave Medical Inc. 3529 Anderson Street Madison, WI 53704
April 3, 2024
FDA Establishment# 3008769756
Date:
Submission Contact: Allison Francis Regulatory Affairs Specialist Phone: 508-728-7585 Email: afranc52@its.jnj.com
Mohamed Shariff Director of Regulatory Affairs Phone: 856-449-9609 Email: msharif3@its.jnj.com
Device Identification
| Device Trade Name: | ABLATE-IQ TM |
|---|---|
| Common Name: | System, X-Ray, Tomography, Computed |
| Classification Name: | Computed tomography x-ray system |
| Device Class: | Class II |
| Product Code: | JAK |
| CFR Section: | 21 CFR 892.1750 |
Predicate Device
ABLATE-IQ™ is substantially equivalent to the following currently marketed device: Predicate Device - Ablation Confirmation (K192427) NeuWave Medical, Inc.
Indications for Use
ABLATE-IQ™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWA VE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.
ABLATE-IQTM 510(k) Summary Page 1 of 10
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Device Description
ABLATE-IQ™ formally known as Ablation Confirmation, is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE System. ABLATE-IQ™ is resident on the NEUWAVE Microwave Ablation System and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. ABLATE-IO™ functions are controlled via a USB connected mouse. ABLATE-IQ™ connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol over the hospital network. DICOM enables the integration of scanners, servers, workstations, printers, and network hardware from multiple manufacturers into an electronic PACS.
ABLATE-IQTM contains a wide range of image processing tools, including:
- · 2D image manipulation
- · 3D image generation (from 2D images)
- · 3D image manipulation
- · Region of interest (ROI)/target identification, segmentation, and measurement
- · Image-based detection of ablation probes manually placed by the user (physician)
- · Registration of multiple images into a single view
Modifications
This 510(k) was submitted to update the Ablation Confirmation software with the following modifications:
- · Planning (New Premium Feature that is optionally licensed for 3.2.0): Probe Insertion Path Planning is an optional feature that allows the user to pre-plan the location and trajectory of the probe(s) relative to a pre-defined target(s). Proposed Ablation Zone Display allows the user to try different combinations of time and power derived from ex-vivo animal tissue data to help users visualize proposed ablation zones with targets and does not provide a clinical representation of tissue to be ablated.
- · Reporting (New Premium Feature that is optionally licensed for 3.2.0): Generation of an electronic report containing procedural information (e.g., ablation time and power used), data related to the target, and the treatment zone dimensions is also a new optional software feature available. The resulting report can be stored to the Hospital PACS.
- · Workflow Updates (page combinations): Prior to 3.2.0, the software had ten steps the user was required to step through. In 3.2.0, the ABLATE-IQ™ navigation groups similar workflow steps together under 3 major workflow pages.
- · Profiles: The system can apply default settings for procedure selectable features and recall those in a procedure selectable way. The default settings do not control the NEUWAVE system nor probe output in any way.
- · Cybersecurity: New cybersecurity features were added for additional protection and compliance
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Comparison of Subject Device and Predicate Device
ABLATE-IQ™ software version 3.2.0 has the same or similar technological characteristics as the predicate device and therefore is substantially equivalent to the predicate device.
| Attribute | Subject Device
ABLATE-IQTM
K232227 | Predicate Device
Ablation Confirmation
K192427 | Comparison |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NeuWave Medical | NeuWave Medical | Same |
| Product Code | JAK | JAK | Same |
| Regulation
Number | 892.1750 | 892.1750 | Same |
| Indications
for Use | ABLATE-IQTM assists
physicians in
identifying ablation
targets, assessing
proper ablation probe
placement and
visualizing treatment
zones when used with
the NEUWAVE
Microwave Ablation
System (NEUWAVE
System). The software
is not intended for
diagnosis, to predict
ablation volume, or to
predict ablation
success. | Ablation ConfirmationTM
(AC), is a Computed
Tomography (CT) image
processing software
package available as an
optional feature for use
with the NEUWAVE
Microwave Ablation
System. AC is controlled
by the user via an
independent user
interface on a second
monitor separate from
the NEUWAVE
Microwave Ablation
System user interface.
AC imports images from
CT scanners and facility
PACS systems for
display and processing
during ablation
procedures. AC assists
physicians in identifying
ablation targets,
assessing proper ablation
probe placement and
confirming ablation
zones. The software is
not intended for
diagnosis. | Same, the subject device
indications for use is the
same as the underlined text
from the predicate device.
The verbiage of the
Indications for Use of the
subject device is slightly
different than the declared
predicate as the text is
being reduced for clarity.
The change in verbiage
does not alter the intended
use of the device as
compared to the predicate
device. |
| Attribute | Subject Device
ABLATE-IQTM
K232227 | Predicate Device
Ablation Confirmation
K192427 | Comparison |
| Image
Acquisition | The system is capable
of retrieving CT image
data, conforming to the
DICOM standard.
Additionally, fused PET
images and MR images can
be imported for the
comparison scan feature. | The system is capable
of retrieving CT image
data, conforming to the
DICOM standard.
Additionally, fused PET
images and MR images can
be imported for the
comparison scan feature. | Same |
| 2D Image
Manipulation | The system provides tools
to manipulate the 2D
image data. The tool set
includes:
Window/LevelPan/ZoomImage ScrollingPoint
measurement
(HU and
coordinate)Distance
measurementRotation | The system provides tools
to manipulate the 2D
image data. The tool set
includes:
Window/LevelPan/ZoomImage ScrollingPoint
measurement
(HU and
coordinate)Distance
measurementRotation | Same |
| 3D Image
Generation | The system is able to
generate a 3D image
based upon the 2D
image series. | The system is able to
generate a 3D image
based upon the 2D
image series. | Same |
| 3D Image
Manipulation | The system provides tools
to manipulate the 3D
image rendering.
These tools include:
RotationPan/ZoomWindow/LevelDistance between tips
when multiple probes
are detected | The system provides tools
to manipulate the 3D
image rendering.
These tools include:
RotationPan/ZoomWindow/LevelDistance between tips
when multiple probes
are detected | Same |
| Attribute | Subject Device
ABLATE-IQTM | Predicate Device
Ablation Confirmation | Comparison |
| | K232227 | K192427 | |
| Region of
Interest (ROI)
Identification | The system allows the
user to semi-
automatically define
regions of interest on CT
images. A single- step
"undo" function was
added to this feature. | The system allows the
user to semi-
automatically define
regions of interest on CT
images. A single- step
"undo" function was
added to this feature. | Same |
| ROI
Measurements | The system allows the
user to assess the volume
of the defined ROIs. | The system allows the
user to assess the volume
of the defined ROIs. | Same |
| Desired Margin
Identification | The system allows the users
to draw on the ROI images
to visualize a user-
determined desired margin
for the ablation procedure. | The system allows the
users to draw on the ROI
images to visualize a user-
determined desired margin
for the ablation procedure. | Same |
| Registration | The system can perform
deformable registration on
two distinct CT images.
The user can manually
adjust the results of the
registration process.
Replaced 'Refine
Registration' capability
with a 'Manual
Registration' capability.
When using the manual
registration, the user has
the option of turning off
the deformations computed
by the deformable
registration. | The system can perform
deformable registration on
two distinct CT images.
The user can manually
adjust the results of the
registration process.
Replaced 'Refine
Registration' capability
with a 'Manual
Registration' capability.
When using the manual
registration, the user has
the option of turning off
the deformations computed
by the deformable
registration. | Same |
| Attribute | Subject Device
ABLATE-IQTM
K232227 | Predicate Device
Ablation Confirmation
K192427 | Comparison |
| Probe
Identification | The system can
automatically identify
ablation probes within the
scan. ABLATE-IQTM can
detect up to 3 probes.
The software also enables
the user to manually draw
probes. | The system can
automatically identify
ablation probes within the
scan. AC can detect up to
3 probes.
The software also enables
the user to manually draw
probes. | Same |
| Probe Placement
Assessment | The system, using the
deformable registration
process, can visualize the
position of the ablation
probe(s) in relation to the
ROI. | The system, using the
deformable registration
process, can visualize the
position of the ablation
probe(s) in relation to the
ROI. | Same |
| Ablation Zone
Assessment | Using the same process as
ROI identification, the
system allows the user to
semi- automatically
identify the ablation zone
following an ablation
procedure. | Using the same process as
ROI identification, the
system allows the user to
semi- automatically
identify the ablation zone
following an ablation
procedure. | Same |
| Allows User to
Account for
Tissue
Contraction | Yes | Yes | Same |
| Tissue
Contraction
Ranges - Liver | ABLATE-IQTM with
V3.2.0 SW allows users
to apply 0%, 10%, 15%,
20% or 30% tissue
contraction to identified
target during the
"Evaluate Ablation
Zone" step in the
workflow or
automatically based
upon default settings. | Ablation Confirmation
with V3.1.0 SW allows
users to apply 0%, 10%,
15%, 20% or 30%
tissue contraction to
identified target during
the "Evaluate Ablation
Zone" step in the
workflow or
automatically based
upon default settings. | Same |
| Attribute | Subject Device
ABLATE-IQTM
K232227 | Predicate Device
Ablation Confirmation
K192427 | Comparison |
| Tissue
Contraction
Ranges - Kidney | ABLATE-IQTM with
V3.2.0 SW allows users to
apply 0%, 10%, 15%,
20% or 30% tissue
contraction to identified
target during the
"Evaluate Ablation Zone"
step in the workflow or
automatically based upon
default settings. | Ablation Confirmation
with V3.1.0 SW allows
users to apply 0%, 10%,
15%, 20% or 30% tissue
contraction to identified
target during the
"Evaluate Ablation Zone"
step in the workflow or
automatically based upon
default settings. | Same |
| Tissue
Contraction
Ranges - Lung | ABLATE-IQTM with
V3.2.0 SW allows users to
apply 0%, 10%, 20%,
30%, 40% or 50%
tissue contraction to
identified target during
the "Evaluate Ablation
Zone" step in the
workflow or
automatically based
upon default settings | Ablation Confirmation
with V3.1.0 SW allows
users to apply 0%, 10%,
20%, 30%, 40% or 50%
tissue contraction to
identified target during
the "Evaluate Ablation
Zone" step in the
workflow or
automatically based
upon default settings. | Same |
| Assessing the
technical success
of the ablation
procedure | Using the same
deformable registration
process, image set with
ablation zone can be
overlaid onto the image
set with the initial ROI
segmentation to help
physicians determine the
technical success of an
ablation procedure.
Allow user to view the
Set Up scan next to the
Evaluate Ablation scan. | Using the same
deformable registration
process, image set with
ablation zone can be
overlaid onto the image
set with the initial ROI
segmentation to help
physicians determine the
technical success of an
ablation procedure.
Allow user to view the
Set Up scan next to the
Evaluate Ablation scan. | Same |
| Attribute | Subject Device
ABLATE-IQ™
K232227 | Predicate Device
Ablation Confirmation
K192427 | Comparison |
| Snapshots | User can take
snapshots of any view
and send to the facility
PACS for achieving, if
desired. | User can take snapshots
of any view and send to
the facility PACS for
achieving, if desired. | Same |
| Remote Viewing | No remote viewing
capability | No remote viewing
capability | Same |
| Orthogonal 2D
Viewing | Axial, Sagittal,
Coronal, "Needle" and
"Periscope"
presentation options. | Axial, Sagittal, Coronal,
"Needle" and
"Periscope" presentation
options. | Same |
| Workflow | 3 workflow pages
Prior to 3.2.0, the
software had ten steps
the user was required
to step through. In
3.2.0, the ABLATE-IQ™ navigation
groups similar
workflow steps
together under 3 major
workflow pages. | 10 workflow pages | Different |
| Reporting | New optional
reporting feature
added for version 3.2.0
software. | No reporting feature
available. | Different |
| Profiles | The system can apply
default settings for
procedure selectable
features and recall
those in a procedure
selectable way.
The default settings do
not control the
NEUWAVE system
nor probe output in
any way. | No profile feature
available. | Different |
| Planning | New optional feature
added for software
version 3.2.0. | No planning feature
available. | Different |
| Attribute | Subject Device
ABLATE-IQ™ | Predicate Device
Ablation Confirmation | Comparison |
| | K232227 | K192427 | |
| Cybersecurity | ABLATE-IQ™ V3.2.0
is a software only
device resident on the
NEUWAVE
Microwave Ablation
System. Cybersecurity
updates were made to
software V3.2.0 on the
NEUWAVE
Microwave Ablation
System. Cybersecurity
updates in V3.2.0
software on the
NEUWAVE
Microwave Ablation
System include:
● Whitelisting
Amendments
● Shell Lockdown
Amendments
● Firewall Rule
Amendments
● Bitlocker
● Remove Remote
Code
● Component
Removal
Cleanup | Ablation Confirmation
V3.1.0 is a software only
device resident on the
NEUWAVE Microwave
Ablation System.
Cybersecurity controls in
V3.1.0 software on the
NEUWAVE Microwave
Ablation System include:
● Whitelisting
● Shell Lockdown
● Firewall | Similar.
The NEUWAVE
Microwave Ablation
System software V3.2.0
includes new
cybersecurity features for
additional protection and
compliance. |
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Image /page/7/Picture/0 description: The image shows a green sphere with a white, stylized wave design on its surface. The sphere has a glossy appearance, suggesting it may be made of glass or a similar material. The wave design is abstract and appears to be a single, continuous line that curves and flows across the sphere's surface.
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Image /page/8/Picture/0 description: The image is a logo that features a green sphere with a white, stylized wave-like design on its surface. The sphere has a glossy appearance, suggesting a three-dimensional effect. The white design is abstract and could be interpreted as a stylized wave or a flowing shape. The overall design is simple and modern, with a focus on the contrast between the green sphere and the white design.
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Image /page/9/Picture/0 description: The image is a circular logo with a light green background. A stylized white wave design is in the center of the circle. The wave appears to be a single, continuous line that curves and tapers to create a dynamic, flowing shape. The logo has a simple and clean design.
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Image /page/10/Picture/0 description: The image shows a circular logo with a light green background. A stylized white wave-like design is prominently displayed in the center of the circle. The wave appears to be moving from left to right, creating a dynamic and fluid impression.
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Image /page/11/Picture/0 description: The image shows a circular logo with a light green background. A stylized white wave-like design is centrally positioned within the circle. The wave appears to be a single, continuous line that curves and tapers, creating a sense of motion or flow. The logo is simple and clean, with a focus on the contrast between the green background and the white wave.
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Image /page/12/Picture/0 description: The image shows a circular logo with a light green background. A white, stylized wave-like design is prominently displayed in the center of the circle. The logo has a glossy appearance, suggesting a three-dimensional effect.
Non-Clinical and/or Clinical Tests Summary & Conclusions
ABLATE-IQ™ was tested in accordance with an established test plan that fully evaluated all functions performed by the software. Design verification documents were developed to provide evidence for unit, integration, system level, regression, information security, and validation software tests. Additionally, User Requirement, Design Requirement, and Design Specification testing was reports were developed. The ABLATE-IQ™ software passed all pre-determined acceptance criteria identified in the test plan.
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks arising from the new or updated features were analyzed and satisfactorily mitigated in the device design and labeling.
ABLATE-IQ™ software V3.2.0 is substantially equivalent in design concepts, technologies and operating principle to the identified predicate. This version of the ABLATE-IQ™ does not present any new questions of safety or effectiveness.
Conclusion
The subject device, ABLATE-IQ™ software version 3.2.0, has the same or similar technological characteristics as the predicate device and therefore is substantially equivalent to the predicate device. Based on the intended use, technological characteristics, and non-clinical performance data, the modified software of ABLATE-IQ™ is substantially equivalent to the predicate device.